Target species
Cattle, Horses and Pigs
Indications for use, specifying the target species:
In horses:
•alleviation of inflammation and pain associated with musculo-skeletal disorders.
•alleviation of visceral pain associated with colic.
•adjunctive therapy in the treatment of endotoxaemia and septic shock.
In cattle:
•reduction of acute inflammation associated with respiratory disease.
•adjunctive therapy in the treatment of acute mastitis.
In pigs:
•Adjunctive therapy in the treatment of swine respiratory diseases.
Contraindications:
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding, where there is evidence of a blood dyscrasia.
•Do not use in case of hypersensitivity to flunixin meglumine, other NSAIDs or any of the excipients.
•Do not use in case of haemorrhagic disorders.
•Do not use in animals suffering from chronic musculo-skeletal disorders.
•Do not administer to pregnant sows, gilts at mating and in breeding boars.
•Do not use the product within 48 hours before expected parturition in cows.
Special Warnings for Each Target Species:
The cause of the underlying inflammatory condition should be determined and treated with appropriate concomitant therapy.
Special Precautions for Use:
Special precautions for use in animals:
•Avoid intra-arterial injection.
•Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.
•Avoid use in any dehydrated, hypovolaemic or hypotensive animal except in the case of endotoxaemia or septic shock.
•It is preferable that NSAIDs, which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.
•Do not use in piglets weighting less than 6 kg.
•NSAIDS are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post- partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae.
Special precautions for the protection of the environment:
Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.
Special precautions to be taken by the person administering the product to the animals:
The veterinary medicinal product may cause reactions in sensitive individuals.
People with known hypersensitivity to non-steroidal anti-inflammatory products and/or to polyethylene glycol should not handle the veterinary medicinal product.
Reactions may be serious.
•• To avoid possible sensitisation reactions, avoid contact with the skin. Personal gloves should be worn when handling this
•• In case of skin contact, wash exposed area with plenty of water and soap. If
•symptoms persist seek medical advice.
•• Avoid eye contact. In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.
•• Avoid accidental self-injection. In case of accidental self-injection, seek medical
•advice immediately and show the package leaflet or the label to the physician.
•• Wash hands after use
Other precautions:
None.
Adverse reactions (frequency and seriousness):
Cattle, horses.
Rare (1 to 10 animals / 10,000 animals treated): | Anaphylaxis1 ; Neurological signs1 (such as Convulsion, Loss of consciousness and Ataxia); |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorder (Gastrointestinal irritation, Gastrointestinal ulceration); Renal disorder2 ; Hepatic disorder3 ; |
1 Very rare frequency in cattle. May be exacerbated by intra-arterial injection.
2 Especially in dehydrated or hypovolaemic animals.
3 Idiosyncrasic reactions
Pigs.
Undetermined frequency (cannot be estimated from the available data): | Injection site irritation1 ; Digestive tract disorder (Gastrointestinal irritation, Gastrointestinal ulceration); Renal disorder2 ; Hepatic disorder3 ; |
1Transient. Resolves spontaneously within 14 days
2 Especially in dehydrated or hypovolaemic animals.
3 Idiosyncrasic reactions
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay:
May be used in pregnant and lactating cattle.
For pregnant mares, use only according to the benefit/risk assessment by the Responsible Veterinarian.
Do not administer to pregnant sows, gilts at mating and in breeding boars.
The product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae.
Interactions with other medicinal products and other forms of interaction:
Monitor drug compatibility closely where adjunctive therapy is required.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other, as it may increase the toxicity, mainly gastro-intestinal, even with low doses of acetylsalicylic acid. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.
The concurrent administration of corticoids may increase toxicity of the two products and increase the risk of gastro-intestinal ulceration. It should therefore be avoided.
Flunixin may reduce the effect of some anti-hypertensive medicinal product by inhibition of the prostaglandins synthesis, such as diuretics, Angiotensin Conversion Enzyme (ACE) inhibitors and beta blockers. Concurrent administration of potentially nephrotoxic drugs, particularly aminoglycosides, should be avoided.
Flunixin may reduce renal elimination of some drugs and increase their toxicity (for example, aminoglycosides).
Amount to be administered and administration route:
For intravenous administration to cattle and horses.
HORSES:
For use in equine colic, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight. Treatment may be repeated once or twice if colic recurs.
For use in musculo-skeletal disorders, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight, once daily for up to 5 days according to clinical response.
For the treatment of endotoxaemia or septic shock associated with gastric torsion and with other conditions in which the circulation of blood to the gastrointestinal tract is compromised: 0.25 mg/kg (1 ml per 200 kg) every 6-8 hours.
CATTLE:
The recommended dose rate is 2.2 mg flunixin/kg bodyweight equivalent to 2 ml per 45 kg bodyweight. Repeat as necessary at 24 hour intervals for up to 5 consecutive days.
For intramuscular injection to pigs.
PIGS:
The recommended dose rate is 2 ml per 45 kg bodyweight (equivalent to 2.2 mg flunixin/kg) once by intramuscular injection, in the neck, in conjunction with appropriate antimicrobial therapy. The injection volume should be limited to a maximum of 5 ml per injection site.
An appropriate graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
The stopper should not be punctured more than 50 times. A draw-off needle should be used to avoid excessive puncturing of the stopper.
Do not exceed the stated dose or duration of treatment.
Overdose (symptoms, emergency procedures, antidotes) (if necessary):
Overdosage is associated with gastrointestinal toxicity.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance.
Not applicable.
Withdrawal periods:
Cattle:
•Meat and offal: 10 Days
•Milk: 24 Hours
Horses:
•Meat and offal: 10 Days
•Milk: The product is not authorised for use in lactating mares producing milk for human consumption.
Pigs:
•Meat and offal: 22 Days